EP4316392A2 - Instruments et procédés de préparation d'un fémur dans une reconstruction partielle du genou - Google Patents

Instruments et procédés de préparation d'un fémur dans une reconstruction partielle du genou Download PDF

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Publication number
EP4316392A2
EP4316392A2 EP23216244.6A EP23216244A EP4316392A2 EP 4316392 A2 EP4316392 A2 EP 4316392A2 EP 23216244 A EP23216244 A EP 23216244A EP 4316392 A2 EP4316392 A2 EP 4316392A2
Authority
EP
European Patent Office
Prior art keywords
femoral bone
patient
alignment device
integrated
femoral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23216244.6A
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German (de)
English (en)
Other versions
EP4316392A3 (fr
Inventor
Jeffrey N. Yeager
Christopher Ray Cyko
Jason S. Jordan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew Orthopaedics AG
Smith and Nephew Asia Pacific Pte Ltd
Smith and Nephew Inc
Original Assignee
Smith and Nephew Orthopaedics AG
Smith and Nephew Asia Pacific Pte Ltd
Smith and Nephew Inc
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Publication date
Application filed by Smith and Nephew Orthopaedics AG, Smith and Nephew Asia Pacific Pte Ltd, Smith and Nephew Inc filed Critical Smith and Nephew Orthopaedics AG
Publication of EP4316392A2 publication Critical patent/EP4316392A2/fr
Publication of EP4316392A3 publication Critical patent/EP4316392A3/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14—Surgical saws ; Accessories therefor
    • A61B17/15—Guides therefor
    • A61B17/154—Guides therefor for preparing bone for knee prosthesis
    • A61B17/155—Cutting femur
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1725—Guides or aligning means for drills, mills, pins or wires for applying transverse screws or pins through intramedullary nails or pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1717—Guides or aligning means for drills, mills, pins or wires for applying intramedullary nails or pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers

Definitions

  • the present disclosure relates generally to orthopedic devices and instruments, and particularly to a device and/or instrument and accompanying methods for preparing a femur in a partial knee reconstruction.
  • Partial knee replacement or arthroplasty is a surgical procedure in which one of the medial or lateral compartment (sections) of a distal femur and a proximal tibia are replaced with an implanted orthopedic device.
  • partial knee replacement may be used to treat knee arthritis in patients who experience arthritis only in one compartment (section) of the knee joint, rather than throughout the knee joint. It can also be used to provide relief from pain and stiffness in patients who have medical conditions that aren't suitable for total knee replacement.
  • damaged cartilage and bone are removed and replaced only in the diseased compartment of a person's knee. This is in contrast to a total knee replacement, in which bone and cartilage from the entire joint are replaced.
  • known orthopedic devices can be subdivided into resection and resurfacing devices.
  • Resurfacing devices are typically balanced by establishing a desired laxity of the flexion space, then by alternating multiple trialing and reaming steps to establish a balanced knee, or desired amount of flexion and extension imbalance. Often, this requires multiple repetitive steps if enabling technology such as robotics or patient matched cutting blocks are not used.
  • alignment of set-up blocks typically utilize a method that is disconnected from the patient's tibia, established by mechanical operation of the set-up device, or by disconnected devices.
  • the devices used are typically offered in multiple sizes, representing characteristics specific to the size of the chosen implant, sizing is typically chosen by a different device in use previous to the balancing step, or after the extension space is prepared by a device.
  • known resurfacing devices and/or methods typically require a number of steps to prepare the femur including to determine proper flexion/extension space balancing, sizing, and bone preparation.
  • conventional methods may use, prior to bone preparation, sizing guides or spoons to establish component size, which may then be used to determine the proper alignment guide.
  • sizing and alignment guides may be established by drill guides after the bone has been prepared.
  • Alignment of the component or orthopedic implant may be established by mechanical reference to an intramedullary alignment rod.
  • some methods establish flexion/extension and valgus alignment by eye.
  • Rotational alignment may be established either independently (e.g., by eye), by mechanical operation of a guide block with reference to the patient's tibia, or by distension of the joint by a non-interconnected spacer. It is also known to utilize a mechanical alignment device connected to a set up block resting on the tibia, or with additional shims positioned between the alignment device and the patient's tibia.
  • Establishment of joint balance may be determined by provisionally preparing (e.g., reaming) then alternately trialing and additional reaming as necessary.
  • reaming e.g., reaming
  • the bone may be prepared using sequential spherical reaming, sawing, progressive range of motion milling, range of motion reaming, etc.
  • the bone/flexion space may be prepared by utilizing a separate set-up block, with orientation provided by the set-up device, a saw combined with extension space preparation, progressive range of motion milling combined with extension space preparation, a separate set-up block with orientation provided by extension space preparation, a separate resector prior to extension space preparation whereby the un-resected tibia is referenced with respect to joint tension and flexion/extension orientation is set by eye.
  • One disadvantage with known partial knee devices and methods is the relatively larger number of surgical steps and instruments needed to prepare the patient's bone to receive the orthopedic implant.
  • the present disclosure provides an improved surgical instrument and accompanying methods to prepare a femur to receive an implant with fewer surgical steps.
  • the instrument and/or methods may facilitate and/or incorporate pre-balancing of the patient's knee (e.g., measuring space between the patient' unprepared femoral bone and the patient's prepared tibial bone including, for example, in flexion/extension direction) such that flexion and extension space balance, bone preparation, and sizing can be completed with a combined, integrated femoral bone alignment device or instrument.
  • the integrated bone alignment/sizing device is used to prepare the distal and posterior portions of a patient's femoral bone.
  • the integrated bone alignment/sizing device can be used to determine a location, placement, alignment, etc.
  • femoral component e.g., unicompartmental femoral implant
  • Sizing of the femoral component can be determined/confirmed by provided references on the integrated bone alignment/sizing device. Posterior resection/joint space establishment can also be completed using the integrated bone alignment/sizing device.
  • femoral alignment can be set with respect to anatomic landmarks, with or without reference to an intramedullary alignment rod.
  • the integrated femoral bone alignment device includes a femoral alignment guide (e.g., a drill guide) and a cutting or sawing slot.
  • the integrated femoral bone alignment device may include one or more references to establish alignment relative to the unprepared distal and posterior femoral bone.
  • the integrated femoral bone alignment device includes one or more alignment or drill guides for establishing alignment of a unicompartmental femoral implant.
  • the integrated femoral bone alignment device may include one or more cutting slots for preparing a portion of the patient's femoral bone such as, for example, the posterior portion of the patient's femoral bone.
  • the integrated femoral bone alignment device also includes a tongue, projection or foot extending from a rear surface of the device for positioning in the space between the patient's unprepared femoral bone and the patient's tibial bone for provisionally positioning the integrated femoral bone alignment device against the patient's bones.
  • the integrated femoral bone alignment device includes one or more holes or openings for connecting the integrated femoral bone alignment device to an optional intramedullary alignment rod.
  • an alignment guide may be used to couple the integrated femoral bone alignment device to the intramedullary alignment rod.
  • the integrated femoral bone alignment device may also include one or more anatomical reference markers to assist the surgeon in determining one or more degrees of freedom.
  • the integrated femoral bone alignment device may include a first anatomical reference marker extending along a proximal or top end of the device.
  • the integrated femoral bone alignment device may include a second anatomical reference marker extending along a front surface of the device.
  • the integrated femoral bone alignment device may also include a coupling mechanism for coupling, engaging, etc. one or more shims or spacers for positioning the integrated femoral bone alignment device into the space between the patient's prepared tibial bone and unprepared femoral bone to help establish alignment.
  • the coupling mechanism may be in the form of a T-shaped member for slidably receiving the shim or spacer.
  • the integrated femoral bone alignment device may also include an indicator having a tip for contacting the patient's bone.
  • the indicator ensures that the device does not sit proud (or too deep) of the anatomy after bone preparation is completed.
  • an integrated femoral bone alignment device arranged and configured to prepare a patient's unprepared femoral bone in a partial knee reconstruction surgery to receive a unicompartmental femoral implant.
  • the device comprises a top end, a bottom end, a front surface, a rear surface, a medial side surface, and a lateral side surface; a femoral alignment drill guide extending from the rear surface to the front surface, the femoral alignment drill guide arranged and configured to form an alignment hole in a distal end of the patient's femoral bone to establish alignment of the unicompartmental femoral implant; a cutting slot extending from the rear surface to the front surface, the cutting slot being arranged and configured to receive a surgical cutting instrument for resecting a portion of the patient's unprepared femoral bone; and one or more anatomical reference markers to establish alignment of the integrated femoral bone alignment device, and hence the unicompartmental femoral implant, relative to patient's
  • the one or more anatomical reference markers include a first anatomical reference marker extending along a top end of the device from the rear surface towards the front surface; and a second anatomical reference marker extending along a front surface of the device from the top end to the bottom end.
  • the first and second anatomical reference markers assist a surgeon determine internal-external (I-E) and medial-lateral (M-L) placement of the unicompartmental femoral implant.
  • the anatomical reference markers consists one of a series of lines, grooves, slots, markings, or a combination thereof.
  • the integrated femoral bone alignment device further comprises a tongue extending from the rear surface, the tongue being arranged and configured to be positioned in a space between the patient's unprepared femoral bone and the patient's prepared tibial bone for provisionally positioning the integrated femoral bone alignment device against the patient's femoral bone.
  • a distance between the tongue and the cutting slot is a fixed distance, such that resecting a portion of the patient's unprepared femoral bone removes a known thickness of the patient's femoral bone.
  • positioning the tongue in the space between the patient's unprepared femoral bone and the patient's tibial bone establishes anterior-posterior (A-P) placement of the unicompartmental femoral implant.
  • A-P anterior-posterior
  • the integrated femoral bone alignment device further comprises one or more openings formed in the front surface thereof; and an alignment guide arranged and configured to be positioned within the one or more openings for coupling the integrated femoral bone alignment device to an alignment rod referencing the patient's femoral bone.
  • the integrated femoral bone alignment device includes first and second openings positioned on either side of the integrated femoral bone alignment device. In one embodiment, in use, coupling the alignment guide with the integrated femoral bone alignment device and the alignment rod establishes flexion-extension (F-E) and varus-valgus (V/V) alignment of the unicompartmental femoral implant.
  • the integrated femoral bone alignment device further comprises a coupling mechanism for one or more shims, the one or more shims being arranged and configured to slidably engage with the coupling mechanism for positioning the integrated femoral bone alignment device into a space between the patient's prepared tibial bone and the patient's unprepared femoral bone establishes alignment of the unicompartmental femoral implant.
  • the coupling mechanism is in the form of a T-shaped member for slidably receiving the one or more shims.
  • the coupling mechanism is in the form of a slot or female connection for slidably receiving the one or more shims.
  • the integrated femoral bone alignment device further comprises an indicator having a tip for contacting the patient's bone.
  • the integrated femoral bone alignment device further comprises one or more additional drill guides arranged and configured to receive a surgical drill to prepare the patient's bone to receive a fixation feature for the unicompartmental femoral implant.
  • the integrated femoral bone alignment device further comprises one or more holes arranged and configured to receive a fixation member for provisionally coupling the integrated femoral bone alignment device to the patient's unprepared femoral bone.
  • the fixation member is a pin for provisionally coupling the integrated femoral bone alignment device to the patient's unprepared femoral bone.
  • the integrated femoral bone alignment device comprises an outer profile that is asymmetric and arranged and configured for use with either a medial or a lateral portion of the patient's femoral bone.
  • superior-inferior (S-I) placement of the unicompartmental femoral implant is established by contacting the rear surface of the integrated femoral bone alignment device with the patient's unprepared femoral bone.
  • an integrated femoral bone alignment device incorporating an alignment guide (e.g., drill guide) and a cutting slot (e.g., a posterior cutting slot) is used.
  • an access hole is initially drilled into a distal end of the patient's femur.
  • an intramedullary alignment rod is positioned into the access hole.
  • an integrated femoral bone alignment device is provisionally positioned against the patient's unprepared femoral bone.
  • An alignment device is subsequently positioned and coupled to the integrated femoral bone alignment device and to the intramedullary alignment rod to establish alignment with respect to the femur.
  • a drill bit may be used to create an alignment hole in the distal portion of the patient's femur.
  • a saw or cutting blade may be used to resect portions of the patient's bone such as, for example, the posterior portion of the patient's femur.
  • the integrated femoral bone alignment device may be removed and the distal portion of the patient's femur may be prepared using the established reference points including the alignment hole to position an alignment shaft for receiving a rotary mill or cutting tool. Femoral trialing may be completed, and an orthopedic implant may be implanted.
  • the integrated femoral bone alignment device is provisionally positioned against the patient's unprepared femoral bone by inserting a tongue extending from a rear surface of the integrated femoral bone alignment device into the space between the patient's unprepared femur and the patient's tibia.
  • coupling the alignment device with the integrated femoral bone alignment device and the intramedullary alignment rod establishes flexion-extension (F-E) and varus-valgus (V/V) alignment of the unicompartmental femoral implant.
  • anterior-posterior (A-P) placement may be established by contact with the tongue extending from the rear surface of the integrated femoral bone alignment device.
  • superior-inferior (S-I) placement is established by contact with the rear surface of the integrated femoral bone alignment device.
  • the remaining degrees of freedom including internal-external (I-E) and medial-lateral (M-L) placement may be established by hand utilizing one or more anatomical reference markers on the integrated femoral bone alignment device.
  • creating the alignment hole in the distal portion of the patient's femur may be used by a preparation device to establish extension space balance.
  • resecting portions of the posterior portion of the patient's femur establish flexion space balance.
  • the integrated femoral bone alignment device is initially provisionally positioned against the patient's unprepared femoral bone.
  • One or more shims or spacers may be positioned between the integrated femoral bone alignment device and the patient's prepared tibial bone to assist with establishing alignment with respect to the patient's femur.
  • a drill bit is used to create an alignment hole in the distal portion of the patient's femur.
  • a saw or cutting blade may be used to resect portions of the posterior portion of the patient's femur.
  • the integrated femoral bone alignment device may be removed and the distal portion of the patient's femur may be prepared using the established reference points including the alignment hole to position an alignment shaft for receiving a rotary mill or cutting tool. Femoral trialing may be completed, and an orthopedic implant may be implanted.
  • the integrated femoral bone alignment device is initially provisionally positioned by inserting a tongue extending from a rear surface of the device into the space between the patient's unprepared femur and the patient's tibia.
  • the shim may be coupled to the integrated femoral bone alignment device via a coupling mechanism formed on the integrated femoral bone alignment device. Thereafter, the shim may be positioned within the space between the patient's prepared tibial bone and the patient's unprepared femoral bone.
  • a method for preparing a patient's femoral bone for use in a partial knee reconstruction surgery to implant a unicompartmental femoral implant in which the patient's knee has an existing imbalance in the patient's unprepared femoral bone in extension as compared to flexion.
  • the method comprises positioning a tongue extending from a rear surface of an integrated femoral bone alignment device into a patient's knee space between the patient's unprepared femoral bone and the patient's prepared tibial bone, the integrated femoral bone alignment device further including an alignment guide and a cutting slot; inserting a drill into the alignment guide to form an alignment hole in a distal end of the patient's unprepared femoral bone; inserting a saw blade into the cutting slot to resect a posterior portion of the patient's femoral bone; removing the integrated femoral bone alignment device; and preparing the patient's femur utilizing the alignment hole.
  • the method further comprises forming an access hole into a distal end of the patient's unprepared femoral bone; inserting an alignment rod into the access hole; and coupling an alignment device to the integrated femoral bone alignment device and to the alignment rod.
  • coupling the alignment device to the integrated femoral bone alignment device and to the alignment rod comprises inserting a projection formed on a first end of the alignment device into a hole formed in the integrated femoral bone alignment device; and positioning a fork-like second end portion of the alignment device about the alignment rod.
  • coupling the alignment device to the integrated femoral bone alignment device and the alignment rod establishes flexion-extension (F-E) and varus-valgus (V/V) alignment of the unicompartmental femoral implant.
  • the method further comprises inserting an alignment shaft into the alignment hole; and positioning a rotary cutting tool over the alignment shaft to prepare the patient's unprepared femoral bone.
  • the method further comprises inserting one or more shims within the patient's knee space between the integrated femoral bone alignment device and the patient's prepared tibial bone to establish alignment of the unicompartmental femoral implant with respect to the patient's femoral bone, the one or more shims being coupled to the integrated femoral bone alignment device.
  • a distance between the tongue and the cutting slot is a fixed distance such that resecting a posterior portion of the patient's unprepared femoral bone removes a known thickness of the patient's femoral bone.
  • the integrated femoral bone alignment device further includes a first anatomical reference marker extending along a top end of the integrated femoral bone alignment device and a second anatomical reference marker extending along a front surface of the integrated femoral bone alignment device, the method further comprises using the first and second anatomical reference markers to establish internal-external (I-E) and medial-lateral (M-L) placement of the unicompartmental femoral implant.
  • I-E internal-external
  • M-L medial-lateral
  • positioning the tongue into the patient's knee space establishes anterior-posterior (A-P) placement of the unicompartmental femoral implant.
  • positioning the tongue into the patient's knee space comprises contacting a rear surface of the integrated femoral bone alignment device with the patient's unprepared femoral bone to establish superior-inferior (S-I) placement of the unicompartmental femoral implant.
  • S-I superior-inferior
  • femoral component e.g., unicompartmental femoral implant
  • pre-balancing the patient's knee can be accomplished so that flexion and extension space balance, bone preparation, and sizing can be completed with a single integrated device.
  • the integrated femoral bone alignment device includes an alignment guide (e.g., drill guide) and a cutting or sawing slot.
  • the integrated femoral bone alignment device may include references to establish alignment to the unprepared distal and posterior femoral bone.
  • the integrated femoral bone alignment device of the present disclosure may, however, be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will convey certain example embodiments of the device and method to those skilled in the art.
  • like numbers refer to like elements throughout unless otherwise noted.
  • FIG. 1 illustrates an embodiment of a bone alignment device such as, for example, an integrated femoral bone alignment device 100 for use in preparing a patient's femur or femoral bone undergoing a partial knee reconstruction procedure.
  • the integrated femoral bone alignment device 100 integrates a femoral alignment guide (e.g., a drill guide), a cutting or sawing slot, and references to establish alignment to the unprepared distal and posterior femoral bone.
  • a femoral alignment guide e.g., a drill guide
  • a cutting or sawing slot e.g., a cutting or sawing slot
  • the integrated femoral bone alignment device 100 includes an anterior or top end 102, a posterior or bottom end 104, a front surface 106, a rear surface 108, a medial or first side surface 110, and a lateral or second side surface 112.
  • the integrated femoral bone alignment device 100 may also include one or more alignment or drill guides 114 for establishing alignment of a unicompartmental femoral implant, as will be described in greater detail below. As shown, the one or more drill guides 114 extend from the rear surface 108 to the front surface 106.
  • the integrated femoral bone alignment device 100 may also include one or more cutting slots 116 for preparing a portion of the patient's femoral bone, as will be described in greater detail below.
  • the cutting slot 116 may extend from the rear surface 108 to the front surface 106, and from the first side surface 110 to the second side surface 112.
  • the integrated femoral bone alignment device 100 may also include a tongue, projection or foot 118 (used interchangeably herein without the intent to limit) extending from the rear surface 108 of the device 100.
  • the tongue 118 is arranged and configured to be positioned in the space between the patient's unprepared femoral bone and the patient's tibial bone for provisionally positioning the integrated femoral bone alignment device 100 against the patient's bones.
  • the integrated femoral bone alignment device 100 may include one or more holes or openings 120 for connecting the integrated femoral bone alignment device 100 to an optional intramedullary alignment rod, as will be described in greater detail below.
  • the one or more holes or openings 120 may extend from the front surface 106 towards the rear surface 108.
  • the integrated femoral bone alignment device 100 may include first and second holes or openings 120 positioned on either side of the integrated femoral bone alignment device 100. In use, the appropriate hole or opening 120 may be selected for coupling to the optional intramedullary alignment rod depending on whether the medial or lateral compartment of the patient's bone is being prepared.
  • the integrated femoral bone alignment device 100 may also include one or more anatomical reference markers 122 to assist the surgeon in determining one or more degrees of freedom.
  • the integrated femoral bone alignment device 100 may include an anatomical reference marker 122a extending from the rear surface 108 towards the front surface 106 along the anterior or top end 102 thereof.
  • the integrated femoral bone alignment device 100 may include an anatomical reference marker 122b extending from the anterior or top end 102 to the posterior or bottom end 104 along the front surface 106 thereof.
  • the anatomical reference markers 122 may be used to help determine internal-external (I-E) and medial-lateral (M-L) placement of the unicompartmental femoral implant.
  • I-E internal-external
  • M-L medial-lateral
  • the anatomical reference marker 122 may take any suitable form now known or hereafter developed including, for example, a series of lines, grooves, slots, markings, or the like, or a combination thereof.
  • the integrated femoral bone alignment device 100 may also include a coupling mechanism 124 for coupling, engaging, etc. one or more shims or spacers, as will be shown and described in greater detail below.
  • a shim may be coupled to the integrated femoral bone alignment device 100 for positioning the integrated femoral bone alignment device 100 into the space between the patient's prepared tibial bone and unprepared femoral bone to help establish alignment of the unicompartmental femoral implant.
  • the coupling mechanism 124 may be any now known or hereafter developed coupling mechanism for coupling a shim to the integrated femoral bone alignment device 100.
  • the coupling mechanism 124 may be in the form of a T-shaped member for slidably receiving the shim.
  • the coupling mechanism could be in the form of a dovetail, a keyed arrangement, or the like.
  • the integrated femoral bone alignment device 100 may also include one or more additional drill guides 115 for guiding a drill to, for example, prepare the patient's bone to receive a fixation feature for the unicompartmental femoral implant.
  • the integrated femoral bone alignment device 100 may also include one or more holes 117 for receiving a fixation member for provisionally coupling the integrated femoral bone alignment device 100 to the patient's bone.
  • the hole 117 may be arranged and configured to receive a pin for provisionally coupling the integrated femoral bone alignment device 100 to the patient's bone, although it is envisioned that other fixation members may be used.
  • the methods may be performed using, for example, the integrated femoral bone alignment device 100 described above in connection with FIG. 1 .
  • the methods may be performed using different bone alignment devices.
  • the exemplary methods should not be limited to use with the integrated femoral bone alignment device 100 described above.
  • the exemplary methods utilize an integrated femoral bone alignment device that incorporates an alignment guide (e.g., drill guide) and a posterior cutting slot such as, for example, the integrated femoral bone alignment device 100.
  • the exemplary methods may utilize associated instruments to evaluate the joint space between a patient's unprepared femoral bone and the patient's prepared tibial bone.
  • Optional instruments may also be used to establish reference between an intramedullary alignment rod and the integrated femoral bone alignment device, and instruments to drill holes using the integrated femoral bone alignment device.
  • instruments may be used to utilize the references created by the femoral bone alignment device, to prepare the distal surface of the femoral bone as an establishment of extension space balance.
  • a 2mm imbalance exists between the unprepared femur or femoral bone F and the prepared tibia or tibial bone T. That is, a 2mm imbalance exists whereby the unprepared femur F influences the joint to have an additional 2mm of laxity in extension that is not present in flexion.
  • Figures presented in connection with the example methods disclosed herein are shown with a configuration to correct this imbalance, however, as will be appreciated by one of ordinary skill in the art, this is but one example, and a patient's knee may include more or less imbalance between the unprepared femur F and the prepared tibia T.
  • FIGS. 3A-3G in connection with a first embodiment of an exemplary method for preparing a patient's femur F utilizing an integrated femoral bone alignment device such as, integrated femoral bone alignment device 100, will now be described.
  • an access hole 200 is drilled into the distal end of the patient's femur F and into the intramedullary canal located within the femur F. Thereafter, as shown in FIG. 3B , an intramedullary alignment rod 210 is positioned into the access hole 200.
  • an integrated femoral bone alignment device such as, for example, integrated femoral bone alignment device 100, may be provisionally positioned by, for example, a surgeon's hand, against the patient's unprepared femoral bone F.
  • a tongue 118 extending from the rear surface 108 of the integrated femoral bone alignment device 100 may be positioned in the space between the patient's unprepared femur F and the patient's tibia T for provisionally positioning the integrated femoral bone alignment device 100 against the patient's bones.
  • an alignment device 220 may be positioned and coupled to the integrated femoral bone alignment device 100 and the intramedullary rod 210.
  • the alignment device 220 may be used to establish alignment with respect to the femur concerning flexion-extension (F-E) and varus-valgus (V/V) alignment of the component (e.g., unicompartmental femoral implant).
  • F-E flexion-extension
  • V/V varus-valgus
  • S-I Superior-inferior
  • one or more spacers or shims 300 may be positioned between the integrated femoral bone alignment device 100 and the patient's prepared tibial bone T.
  • the spacer or shim 300 may be used to determine the distance between the unprepared femoral bone F and the prepared tibial bone T.
  • the spacer or shim 300 may be used to assist with establishing alignment with respect to the patient's femur concerning I-E rotation, and providing resistance to aid in establishment of the remaining degrees of freedom.
  • the alignment device 220 may include a first end 222 and a second end 224, the first end 222 may be arranged and configured to engage the integrated femoral bone alignment device 100 while the second end 224 may be arranged and configured to engage the intramedullary alignment rod 210. While the alignment device 220 may be coupled to the integrated femoral bone alignment device 100 and the intramedullary alignment rod 210 by any now known or hereafter developed mechanisms, in one embodiment, as shown, the first end 222 may include a projection extending therefrom for receipt within the one or more holes or openings 120 formed in the integrated femoral bone alignment device 100. Meanwhile, the second end 224 may be arranged in a fork-like configuration having a space for receiving the intramedullary alignment rod 210. A fastener may subsequently be used to coupe the rod 210 to the alignment guide 220.
  • a drill bit 230 may be used to drill, form, create, etc. an alignment hole 235 in the distal portion of the patient's femur F.
  • the alignment hole 235 may be used by a preparation device to establish extension space balance (e.g., alignment hole 235 may be subsequently used as a guide for a separate cutting device as will be described in greater detail below).
  • a saw or cutting blade 240 may be used to resection the patient's femur F to establish flexion space balance by removing a known amount (thickness) of a patient's bone measured relative to a known implant thickness. For example, if the implant thickness is 6mm, the distance from the tongue 118 to the cutting slot 116 would be 6mm to replace the bone removed, or 8mm (or some other amount) if additional (or less) laxity was desired.
  • the distance from the tongue 118 to the cutting slot 116 would be a fixed distance set into the integrated femoral bone alignment device 100 (e.g., the integrated femoral bone alignment device 100 would always resect implant thickness, or 2mm more, etc. as designed).
  • the integrated femoral bone alignment device 100 may be removed and the distal portion of the patient's femur F may be prepared using the established reference points such as, for example, the alignment hole 235 may be used to position an alignment shaft 236 for receiving a rotary mill or cutting tool 250.
  • femoral trialing may be completed, and a trial implant affixed 260 or an orthopedic implant may be implanted.
  • the second exemplary method is substantially similar to the first exemplary method. As will be shown and described, in use, the second exemplary method may be performed without drilling the access hole 200 into the distal end of the patient's femur F for receiving the intramedullary alignment rod 210 for coupling the alignment device 220 to the integrated femoral bone alignment device 100.
  • the integrated femoral bone alignment device 100 may be initially provisionally positioned against the patient's unprepared femoral bone F.
  • the tongue 118 extending from the rear surface 108 of the integrated femoral bone alignment device 100 may be positioned in the space between the patient's unprepared femur F and the patient's tibia T for provisionally positioning the integrated femoral bone alignment device 100 against the patient's bones.
  • one or more spacers or shims 300 may be positioned between the integrated femoral bone alignment device 100 and the patient's prepared tibia T.
  • the shim 300 may be used to determine the distance between the unprepared femoral bone F and the prepared tibial bone T.
  • the shim 300 may be used to assist with establishing alignment with respect to the patient's femur concerning I-E rotation, and providing resistance to aid in establishment of the remaining degrees of freedom.
  • the shims 300 fill the space between the integrated femoral bone alignment device 100 and the patient's prepared tibia bone T creating residual tension provided by the soft tissue structures to stabilize the relative position of the bones to each other, and the alignment device to the femoral bone by holding its location to the tibia T.
  • F-E, and V/V alignment of the component are determined by the relative positioning between the patient's femur F and tibia T bones.
  • the shim 300 may be positioned into engagement with the coupling mechanism 124 formed on the integrated femoral bone alignment device 100 and slide into the space between the patient's prepared tibial bone T and the patient's unprepared femoral bone F.
  • A-P placement may be established by contact with the tongue 118 extending from the rear surface 108 of the integrated femoral bone alignment device 100, and S-I placement may be established by contact with the rear surface 108 of the integrated femoral bone alignment device 100.
  • the remaining degree of freedoms, with respect to M-L, F/E, and V/V placement may be established by hand, potentially with aid of the anatomical reference markers 122a, 122b formed on the integrated femoral bone alignment device 100.
  • the anatomical reference markers 122a, 122b may be aligned with the center of the prepared tibia T.
  • a drill bit 230 may be used to drill, form, create, etc. an alignment hole 235 in the distal portion of the patient's femur F.
  • the alignment hole 235 may be used by a preparation device to establish extension space balance (e.g., alignment hole 235 may be subsequently used as a guide for a separate cutting device).
  • a saw or cutting blade 240 may be used to resection the patient's femur F to establish flexion space balance by removing a known amount (thickness) of a patient's bone measured relative to a known implant thickness. For example, as previously described, if the implant thickness is 6mm, the distance from the tongue 118 to the cutting slot 116 would be 6mm to replace the bone removed, or 8mm (or some other amount) if additional (or less) laxity was desired.
  • the distance from the tongue 118 to the cutting slot 116 would be a fixed distance set into the integrated femoral bone alignment device 100 (e.g., the integrated femoral bone alignment device 100 would always resect implant thickness, or 2mm more, etc. as designed).
  • the integrated femoral bone alignment device 100 may be removed and the distal portion of the patient's femur F may be prepared using the established reference points such as, for example, the alignment hole 235 may be used to position an alignment shaft 236 for receiving a rotary mill or cutting tool 250.
  • femoral trialing may be completed, and a trial implant affixed 260 or an orthopedic implant may be implanted.
  • FIGS. 5A-5D illustrate an alternate embodiment of a bone alignment device such as, for example, an integrated femoral bone alignment device 400 for use in preparing a patient's femoral bone undergoing a partial knee reconstruction procedure.
  • the integrated femoral bone alignment device 400 may integrate a femoral alignment guide (e.g., a drill guide), a cutting or sawing slot, and references to establish alignment to the unprepared distal and posterior femoral bone, and may be used in connection with the methods previously described.
  • the integrated femoral bone alignment device 400 however may be characterized as a handed device.
  • the integrated femoral bone alignment device 400 is arranged and configured to contact either the medial or lateral portion of the patient's femoral bone (e.g., the outer profile of the integrated femoral bone alignment device 400 is asymmetric and arranged and configured for use with either the medial or lateral portion of the patient's femur).
  • the integrated femoral bone alignment device 400 is arranged and configured to contact a lateral portion of the patient's bone (e.g., femur).
  • a similar device may also be provided for contacting a medial portion of the patient's bone (e.g., femur).
  • the integrated femoral bone alignment device 400 includes an anterior or top end 402, a posterior or bottom end 404, a front surface 406, a rear surface 408, a medial or first side surface 410, and a lateral or second side surface 412.
  • the integrated femoral bone alignment device 400 may also include one or more alignment or drill guides 414 for establishing alignment of a unicompartmental femoral implant as previously described.
  • the one or more drill guides 414 extend from the rear surface 408 to the front surface 406 and may be used to prepare, for example, a primary peg for subsequent preparation steps).
  • the integrated femoral bone alignment device 400 may also include one or more cutting slots 416 for preparing a portion of the patient's femoral bone, as previously described.
  • the cutting slot 416 may extend from the rear surface 408 to the front surface 406, and from the first side surface 410 to the second side surface 412.
  • the integrated femoral bone alignment device 400 may also include a tongue, projection or foot 418 (used interchangeably herein without the intent to limit) extending from the rear surface 408 of the device 400.
  • the tongue 418 is arranged and configured to be positioned in the space between the patient's unprepared femoral bone and the patient's tibial bone for provisionally positioning the integrated femoral bone alignment device 400 against the patient's bones.
  • the integrated femoral bone alignment device 400 may include one or more holes or openings 420 for connecting the integrated femoral bone alignment device 400 to an optional intramedullary alignment rod 210 (as illustrated in FIG. 5B ).
  • the one or more holes or openings 420 may extend from the front surface 406 towards the rear surface 408.
  • the opening 420 may be positioned adjacent to the medial or first side surface 410 for the lateral, integrated femoral bone alignment device 400.
  • the opening 420 may be positioned adjacent to the lateral or second side surface 412 for the medial, integrated femoral bone alignment device 400.
  • the integrated femoral bone alignment device 400 may also include one or more anatomical reference markers 422, as previously described, to assist the surgeon in determining one or more degrees of freedom.
  • the integrated femoral bone alignment device 400 may include an anatomical reference marker 422 extending from the anterior or top end 402 to the posterior or bottom end 404 along the front surface 406 thereof.
  • the integrated femoral bone alignment device 400 may include an anatomical reference marker (not shown) extending from the rear surface 408 towards the front surface 406 along the anterior or top end 402 thereof.
  • the anatomical reference markers 422 may be used to help determine internal-external (I-E) and medial-lateral (M-L) placement of the unicompartmental femoral implant.
  • I-E internal-external
  • M-L medial-lateral
  • the anatomical reference marker 422 may take any suitable form now known or hereafter developed including, for example, a series of lines, grooves, slots, markings, or the like, or a combination thereof.
  • the integrated femoral bone alignment device 100 may also include a coupling mechanism 424 for coupling, engaging, etc. one or more shims or spacers, as previously described.
  • a shim may be coupled to the integrated femoral bone alignment device 400 for positioning the integrated femoral bone alignment device 400 into the space between the patient's prepared tibia and unprepared femur to help establish alignment of the unicompartmental femoral implant.
  • the coupling mechanism 424 may be any now known or hereafter developed coupling mechanism for coupling a shim to the integrated femoral bone alignment device 400.
  • the coupling mechanism 424 may be in the form of a slot or female connection to slidably receive the shim, spacer, or the like.
  • the coupling mechanism could be in the form of a male connection member such as, for example, a T-shaped member, a dovetail, a keyed arrangement, or the like.
  • the integrated femoral bone alignment device 400 may also include one or more additional drill guides 415 for guiding a drill to, for example, prepare the patient's bone to receive a fixation feature for the implant (e.g., opening to prepare, for example, a secondary peg).
  • the integrated femoral bone alignment device 400 may also include one or more holes 417 for receiving a fixation member for provisionally coupling the integrated femoral bone alignment device 400 to the patient's bone.
  • the hole 417 may be arranged and configured to receive a pin for provisionally coupling the integrated femoral bone alignment device 400 to the patient's bone, although it is envisioned that other fixation members may be used.
  • the integrated femoral bone alignment device 100 may include an indicator 430 having a tip 432 for contacting the patient's bone.
  • the configuration (e.g., angle, size, or the like) of the integrated femoral bone alignment device 400 may be selected to ensure that the tip 432 of the device 400 doesn't sit proud (or too deep) of the anatomy after bone preparation is completed.
  • the example methods pre-balance the patient's knee to eliminate sequential preparation steps of the distal portion of the patient's femur, however it is envisioned that the methods may be used without pre-balancing the knee and may establish knee balancing via traditional sequential preparation.
  • example methods are illustrated and described in connection with devices having a single articular radius, singular bone facing radius, and a single positive fixation feature, however it is envisioned that the methods could be used to prepare a patient's bone for receiving a device with multiple bone facing or articulating radii, and with multiple, or no positive fixation features.
  • femoral bone alignment devices have been shown and described as including a number of different features, it is envisioned that the femoral bone alignment devices need not include each and every feature described. For example, it is envisioned that femoral bone alignment devices may only include a subset of the features described. For example, the femoral bone alignment devices need not include one or more holes or openings for coupling to an alignment device, one or more anatomic markers, a coupling mechanism for coupling to a shim, etc.
  • the methods described herein may be modified to hold extension space balance constant, to allow variation in flexion space balance, or hold neither constant and allow for varying both extension and flexion balance through modification to femur preparation.
  • multiple integrated femoral bone alignment devices with different resection levels e.g. 6mm, 8mm, 10mm
  • an integrated femoral bone alignment device with multiple cutting slots could be provided.
  • spacers or shims that would have material anterior to tongue could be utilized.
  • the femoral bone alignment devices allow femoral component alignment with an integrated drilling and cutting guide in a single, unitary body. That is, in accordance with the principles described herein, a novel instrument and accompanying methods to prepare a patient's femur to receive an orthopedic implant with a curved distal surface in fewer surgical steps has been disclosed.
  • an integrated bone alignment/sizing device for the femur is provided.
  • the integrated femoral bone alignment device can set the location of the femoral component (e.g., unicompartmental femoral implant) relative to joint tension with reference to a prepared tibia surface. Sizing of the femoral component can also be determined/confirmed by provided references integrated into the femoral bone alignment device. Posterior resection/joint space establishment can also be completed using the integrated femoral bone alignment device.
  • the integrated femoral bone alignment device can achieve femoral alignment with respect to anatomic landmarks, with or without reference to an intramedullary alignment device.
  • the femoral bone alignment device enables a plurality of shims or spacers to be mechanically coupled to the device to provide alignment with reference to a patient's prepared tibia.
  • the femoral alignment device enables alignment with or without an intramedullary rod reference to aid in the alignment component anterior shape is provided in its entirety, along with a marking to reference center of articulation with consideration of fixation features.
  • the integrated femoral bone alignment device facilitates corresponding methods of preparing a patient's femur requiring fewer steps to prepare the femur to receive a trial / implant.
  • steps may be reduced in one or more of the following ways: pre-balancing the knee to eliminate additional steps associated with sequential reaming, milling, or range of motion reaming (e.g., extension space balance can be established by a single reaming/milling step); combination of providing a cutting slot into the guide, eliminates the need for additional guides to complete posterior bone preparation; providing references in a single guide with respect to anterior component shape, center of articulation (and fixation features), and to receive a spacer for alignment without reference to an intramedullary guide, enables optional elimination of the need to violate the intramedullary canal, and the steps associated with creating the intramedullary reference.
  • Connection references are to be construed broadly and may include intermediate members between a collection of elements and relative to movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. All rotational references describe relative movement between the various elements. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority but are used to distinguish one feature from another.
  • the drawings are for purposes of illustration only and the dimensions, positions, order and relative to sizes reflected in the drawings attached hereto may vary.

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EP23216244.6A 2019-08-14 2020-07-06 Instruments et procédés de préparation d'un fémur dans une reconstruction partielle du genou Pending EP4316392A3 (fr)

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US201962886671P 2019-08-14 2019-08-14
PCT/US2020/040899 WO2021029984A1 (fr) 2019-08-14 2020-07-06 Instruments et procédés de préparation d'un fémur dans une reconstruction partielle du genou
EP20747279.6A EP3998963B1 (fr) 2019-08-14 2020-07-06 Instruments de préparation d'un fémur dans une reconstruction partielle du genou

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US11540928B2 (en) * 2017-03-03 2023-01-03 Engage Uni Llc Unicompartmental knee arthroplasty
JP2023519789A (ja) * 2020-02-05 2023-05-15 エンコア メディカル エル ピー 部分的膝インプラントおよびこれを設置するための方法
WO2022235808A1 (fr) * 2021-05-04 2022-11-10 Rasmussen G Lynn Systèmes et méthodes de fourniture d'un système de plaque de base tibiale

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US6695848B2 (en) * 1994-09-02 2004-02-24 Hudson Surgical Design, Inc. Methods for femoral and tibial resection
US6024746A (en) * 1995-05-31 2000-02-15 Lawrence Katz Method and apparatus for locating bone cuts at the distal condylar femur region to receive a femoral prothesis and to coordinate tibial and patellar resection and replacement with femoral resection and replacement
US9020788B2 (en) * 1997-01-08 2015-04-28 Conformis, Inc. Patient-adapted and improved articular implants, designs and related guide tools
CA2537711A1 (fr) * 2006-02-27 2007-08-27 Orthosoft Inc. Ensemble bloc de positionnement universel
EP2259755B1 (fr) * 2006-09-06 2017-01-18 Smith & Nephew, Inc. Implants dotés de surfaces de transition
US8672946B2 (en) * 2011-02-11 2014-03-18 Biomet Manfacturing, LLC Method and apparatus for performing knee arthroplasty
US11992230B2 (en) * 2016-11-30 2024-05-28 G. Lynn Rasmussen Systems and methods for providing a tibial baseplate
GB201809938D0 (en) * 2018-06-18 2018-08-01 Jointmedica Ltd Multifunctional Spacer for Knee Surgery to Achieve Balanced Resection

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EP3998963B1 (fr) 2024-01-10

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